Consent to research: Research involving human tissue

1. 36. You must keep up to date with, and comply with, the laws and codes of practice that apply to the use in research of human organs, tissue and cells. The Human Tissue Authority (HTA) publishes a number of codes of practice,²⁰  including those on consent and research, which advise on the issues you should consider when seeking consent for the purpose of research.
2. 37. In England, Wales and Northern Ireland, the Human Tissue Act 2004 requires consent²¹ to be obtained before the storage and use of a living person’s organs, tissue or cells for the purpose of research in connection with disorders in, or the functioning of, the human body. In a number of specific circumstances, there are exceptions to the consent requirements; for example, a living person’s organs, tissue or cells may be stored and used without consent if the researcher is unable to identify the person it has come from, and if it is used for a specific research project that has been approved by a research ethics committee. The Human Tissue Act 2004 also requires consent to be obtained for the removal, storage and use of a deceased person’s organs, tissue and cells for the purpose of research in connection with disorders in, or the functioning of, the human body.  Regulations²² made under the Human Tissue Act 2004 permit the use and storage of organs, tissue or cells from adults who lack capacity for research under certain circumstances.
3. 38. The Human Tissue (Scotland) Act 2006 requires authorisation to be obtained before the storage and use of a deceased person’s organs, tissue or cells for the purposes of research.²³  The Act does not cover the storage and use of tissue from living people for the purposes of research.
4. 39. The Medicines for Human Use (Clinical Trials) Regulations 2004 apply to the use of tissue in clinical trials of investigational medicinal products.